At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.

So the TGA is certainly not rushing the jump.

Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.

He writes:

“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of  young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to  “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.

As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.

After extensive  internal and external reviews of the evidence surrounding both  efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.

It is certainly true, that the  consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.

Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.

This has, in fact,  been noted in the TGA External Review, where they raise the concept of  “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.

Presumably, in recognition of  the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.

It seems to me that there will need to be long-term educational campaign on this issue, if the  proposed changes are adopted.

Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.

From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations!  This is, of course, quite understandable.

After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.

Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations.  These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.

But, with TGA inviting responses from  stakeholder organisations, it is going to  require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded  infant and childrens’ medicines.”

• A terrific piece bringing some much-needed perspective to discussions about mental illness, especially in the wake of recent murders. By Dr Tanya Ahmed, a registrar in psychiatry and a principal of the health and communications consultancy RaggAhmed.

• More than a million premature deaths across 30 OECD countries could be prevented each year if income inequality was reduced. That’s the best guess of a meta-analysis of studies involving around 60 million people, reported in the BMJ. The authors note that there are many caveats to their findings, including a lack of evidence from developing countries, but say their results have “potentially important policy implications for population health”. Meanwhile, I’m heartened to read that a fellow Crikey blogger is also putting inequality on the public agenda.

• When the law meets public health – Simon Chapman, professor of public health at the University of Sydney, considers the implications of a recent High Court judgment. It dismissed a duty of care negligence claim against a Tasmanian hotel owner who handed back motorcycle keys lodged for safe-keeping to an insistent, belligerent patron who on leaving the pub was killed in a crash while showing a blood alcohol level of 0.253.

• Investigating the ties between drug companies and doctors – A group of researchers from Australia, Canada and the US have done an indepth analysis of disclosures of pharmaceutical sponsorship of gifts and educational events, as has been required of Medicines Australia members since 2007. They conclude that the disclosure does not go far enough and also give some interesting examples of how companies are wooing doctors. Novartis, for example paid flights, accommodation, food, beverages, and conference registration fees for six ophthalmologists to attend a two-day conference in Spain, at a cost of AUD$10,993 per person. For those who follow this field, it will come as no surprise that the researchers include Ray Moynihan, Lisa Bero and David Henry. The other authors are Jane Robertson and Emily Walkom from the University of Newcastle.

The Wall Street Journal reports that Merck has just released its list of payments to doctors for giving talks at promotional events. The list also includes some nurses, pharmacists and scientists.

The payments range from $150 to more than $20,000.

The paper reports that many drug companies are moving to do likewise, and that Eli Lilly published its own list earlier this year.  There is also a political push to require drug companies to report the payments.

It seems that Australia really is dragging the chain in this area.

The advertisement includes a sample from a consumer advertising campaign that advises readers to talk to their doctor about a combination heart pill if they’re taking mubliple medicines for their heart.

The consumer ad incudes a rip-out section to take to the doctor which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”

Croakey readers may remember that earlier this year Michele Kosky, executive director of the Health Consumers’ Council in WA, asked the TGA and Medicines Australia to investigate whether the consumer advertisement breaches the ban on direct-to-consumer advertising of prescription medicines.

In June, Croakey reported back that Kosky had not had any response from the TGA, and that the Medicines Australia code of conduct committee did not consider the advertisement to be promoting a particular product and therefore was not in breach of the code (although this was not a unanimous decision).

It seems worth revisiting the issue, now that Pfizer has started plugging its consumer campaign into its marketing in the medical mags. It doesn’t take much effort to join the dots.

Step 1: Push the consumers into doctors’ surgeries with a reminder to ask about a “combination heart pill”.

Step 2: Back up the consumer advertising campaign with a website like this (with a helpful print out to take to the doctors)

Step 3: Prompt doctors to think of Pfizer when patients start arriving with notes about “a combination heart pill”…

And this doesn’t count as direct-to-consumer advertising???

For the record, Pfizer’s most recent annual review for US shareholders said its combination heart pill, (aka Caduet, aka a combo of its mega-selling cholesterol-lowering drug, Lipitor, and blood pressure pill Norvasc) was worth $589 million in 2008, up four per cent on the previous year.

For those who believe new drugs are all about improving patient care, this article in Pharma Focus explains the strategy behind the development and promotion of combination products like Caduet – as a strategy for defending the impending expiration of Lipitor’s patent in 2011.

Meanwhile, if you want some independent information, here’s the blurb on the combo pill from the National Prescribing Service.

I wonder if Michele Kosky ever heard back from the TGA about her complaint? I will check and let you know…

The interview, conducted by Maryann Napoli from the Center for Medical Consumers in New York, raises many questions about the merits of our mass vaccination program for H1N1.

You can also read more about Jefferson’s views and work in this article from the European magazine, Der Spiegel, in this 2005 news release issued by the University of Oxford, at this Cochrane Collaboration site, and in this recent blog by a Scottish GP, Margaret McCartney, at the Financial Times website.

He is also lead author of this systematic review published a few days ago in the British Medical Journal, examining the use of physical interventions (eg handwashing, masks etc) to interrupt or reduce the spread of respiratory viruses, such as influenza.

It seems like the issues around influenza vaccination generally – and swine flu vaccination in particular – may not be quite as clear cut as they’re often made out to be.

Healthy Skepticism is hosting the panel discussion, at the Women and Children’s Hospital, to examine questions such as:

• Do partnerships with industry (as set out in Australia’s National Medicines Policy) bring about better health  outcomes?

• What are the strengths and deficiencies of our current system of regulation?

• Do the Therapeutic Goods Administration and state regulatory authorities have the political support and resources necessary to maintain objectivity?

• Is public access to regulatory processes and decisions sufficient to properly evaluate the operation of the policy?

The panellists will be:

• Hon Mark Butler MP, Parliamentary Secretary for Health
• Emeritus Prof Lloyd Sansom, AO, Chair, Pharmaceutical Benefits Advisory Committee
• Assoc/Prof Chris Doecke, Director of Pharmacy Services, Royal Adelaide Hospital
• Emeritus Prof Peter McDonald, AM, retired Infectious Diseases physician
• Dr Agnes Vitry, Senior Research Fellow, School of Pharmacy and Medical Sciences, Uni SA
• Dr Ken Harvey, Senior Research Fellow, School of Public Health, La Trobe University
• Dr Jon Jureidini, Head, Department of Psychological Medicine, Women’s & Children’s Hospital, and Chair, Healthy Skepticism
• Dr Peter Mansfield, OAM, GP and Director, Healthy Skepticism

The session will be facilitated by Prof Anne Tonkin Director, Medicine Learning & Teaching Unit, Adelaide University.

And here is the statement announcing the forum:

Healthy Skepticism, the international campaign against misleading health marketing, today called for a major review of government controls of medicines in Australia.

“Vioxx killed more Australians than the Victorian bushfires. Just as we re-think bushfire preparedness, it’s time we re-examined how well the public is protected by pharmaceutical regulation,” said Dr Peter Mansfield, the organisation’s director.

Australian regulatory processes failed to prevent the Vioxx disaster a few years ago because of failure on several fronts: “Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures. … Drug companies ran intense and misleading promotional campaigns. … Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising.”1

Dr Agnes Vitry (School of Pharmacy and Medical Sciences, University of South Australia) says that although Australia has a strong National Medicines Policy compared to most other countries, there are concerns that Australian regulators’ dependence on fees paid by drug companies might create a situation where they are more focused on serving the industry rather than prioritising the interests of public health e.g. by fast-tracking assessments without appropriate data to assess safety issues. The medicines agency requires more power and resources to ensure that safety is actively monitored after drugs are approved.

There are also concerns about Australia’s reliance on industry “self-regulation” to control the advertising and promotion of medicines. As Dr Ken Harvey (School of Public Health, La Trobe University) says, “The focus on self-regulation has produced a plethora of industry codes and complaint systems which makes it difficult for complainants to know where to send a complaint. There are gross inconsistencies between various codes.”

Healthy Skepticism would like to see much more streamlined and effective system, capable of meaningful constraint of companies like Pfizer, whose inappropriate marketing recently prompted US courts to order payment of $2.3 billion.

By contrast, as Harvey says, “Pfizer Australia has had 17 complaints against Medicines Australia (MA) Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such modest fines have reduced Code violations by Pfizer or other member companies. “

1. Vitry A, Lexchin J, Mansfield PR. Is Australia’s national medicines policy failing? The case of COX-2 inhibitors.  Int J Health Serv. 2007;37:735-44.

More details are available here.

Here at Croakey, we thought we’d do our bit to save the public purse by asking some relevant experts for their views about one particular recommendation, and the challenges surrounding its implementation.

This recommendation states (p97):

There should be a common national approach to evaluating all health interventions, with consistent evaluation of medical care, pharmaceuticals, prevention and population health interventions, medical devices and prostheses, allied health and complementary medicine. To use an example this might allow comparison of the relative efficacy of a medical intervention (gastric bypass), a pharmaceutical intervention (an anti-obesity drug), an allied health intervention (a structured program of exercises and diet management) and a population health intervention (a community walking program) in reducing obesity.

Of the experts contacted by Croakey, most liked the general thrust of the recommendation, although several cautions were sounded, and multiple barriers were identified.

Some of the cautions:

Jon Wardle (Qld Uni): The recommendation is certainly good in theory and worth pursuing – though is fraught in many practical ways. I see a well-intentioned measure heading for disaster.

Ben Harris-Roxas (University of NSW), when asked whether the recommendation should be progressed, gave “an emphatic ‘maybe’.” It sounds intuitively appealing but there will be substantial practical and methodological challenges.

Glenn Salkeld, School of Public Health, University of Sydney: It is worth agreeing upon a common set of principles for the evaluation of interventions and then consider the task of how best to evaluate the options. Without a clear articulation of the objectives of resource allocation (which must include the distributional consequences of resource allocation) we run the risk of measuring precisely the wrong thing in an evaluation.

***

Below, in no particular order, are the full responses to our informal survey:

1. Jon Wardle, School of Population Health, University of Queensland

What issues would need to be addressed to enable implementation? There are many barriers. The first is that there seems to be an underlying assumption that the generic nature of reactive pharmaceutical intervention for disease can immediately be transferred to the proactive/preventive treatment of disease. This casually ignores the many socio-cultural or other ‘non-health’ factors that affect the outcome of preventive health measures far more than acute treatments.

It also over-simplifies the methodological challenges in measuring the outcomes of interventions. Some may require a ‘whole-practice’ approach and not have readily identifiable markers of effect (I know of many menopausal interventions that have lower effect on single measures, but are superior on multi-factoral measures like ‘menopause scores’), or some may have patient-centred outcomes that may not be readily identifiable or comparable to clinical scores – but equally important in many aspects (for example the qualitative study of rheumatoid arthritis patients in Bristol that for the first time identified that fatigue associated with the condition, not pain, was the factor that most impacted their life – ‘clinical’ research had not previously explored this area). Of course people are individuals – some may respond better to diet than drugs, some vice versa.

Would a crude comparison make the intervention most effect for that individual unavailable as most other people did not see an effect? I would also suggest that it is not just health interventions that are measured. After all one of the most significant public health initiatives was seat belts – and that had bugger all to do with the health system!

The society in which we live predisposes the population to poor health outcomes (ie social isolation of suburbia; car-focused non-active transport; liquor licensing laws that encourage ‘super-pubs’ and subsequent binge drinking and violence over smaller, more social venues; urban planning that has reduced access to greengrocers, markets or other healthy and cheaper food choices in low SES areas; food safety laws that promote unhealthy options over fresher ones – for example national or processed over local or artisanal foods).

What impact might it have if it was implemented? The potential exists to stifle innovation in the development of health programs if the process is over-centralised or doesn’t deem it fit to focus on a number of similar interventions (ie why is the one ‘diet program’ chosen over another?). The bureaucracy of running it all may actually divert precious resources in the first place!

Do you think that it has any chance of being implemented? What might be some of the barriers? The barriers are too numerous to mention, and many of them involve internal politics, for example it assumes that one groups ‘walking program’ is the gold-standard, or which allied health profession will be chosen? Who will choose? In a sense this is being done already through broad health research funding agencies such as the NHMRC. A more prudent way to achieve this may be to develop research capacity in this new field through special funding rounds and later allow research to be funded on its merit. Although I would love to see the government fund research into each of those interventions my experience of grant rejection (we’ve all been there) makes me a little cynical and think there simply won’t be enough resources to do so.

Are you aware of any other countries that are already doing this? There are many attempts at doing similar things (NICE in the UK) but they are also share as many differences as they do similarities. Collaborations already compare such data already and we may be re-inventing the wheel.

Any other general issues that are worth raising? There are many factors that can affect health, in areas as disparate as transport or retail competition policy (for example it is pointless promoting to eat more vegetables if current retail policy competition means that the duopoly restricts access and affordability to nutritious foods – sorry a shameless plug for an article of mine coming up in ANZJPH). Many of the health issues of the future are particularly susceptible to the implementation of non-health policy and focus on this issue was sorely lacking. Some nations (including New Zealand) are investigating the role of “Health Impact Assessments” on new projects (such as housing estates) or policy and this is an area that should be explored further.

***

2. Chris Del Mar, Dean, Faculty Health Sciences and Medicine, Bond University

This recommendation is a worthy objective. In particular some treatments are currently measured with quite different standards (esp complementary and alternative medicines, where ‘traditional use’ which can be recent, is considered an OK to licence, while other drugs need endless costly evaluation)

What are some of the issues that will need to be addressed to enable implementation? We need to facilitate randomised controlled trials more easily. Currently these are difficult to get done. Multiple ethics committees etc. In fact an RCT needs a higher standard of care than ordinary treatment (even if unproved!)

What impact might it have if it was implemented? People (patients and their doctors) should be encouraged to partner more in RCT evaluation of novel treatments. Currently this is seen as a ‘predator-prey’ relationship, which the trial funders are trying to make a buck for the shareholders, which is OK sometimes, but often there is a value to society by the RCT taking place and we all benefiting for the knowledge.

Do you think that it has any chance of being implemented? Yes, if we can change attitudes here.

***

3. Michele Kosky, Health Consumers Council WA

Great idea, let’s have treatment based on best evidence and most cost effective for patient and the funder. I think it would reduce the competing interests and the territory wars between the tribes of health professionals that we often witness and it could be graded so that the gastric banding, for example, becomes treatment of last resort with all its inherent risks. I think that the industry groups in health and the pharmaceutical industry will ensure this proposal does not happen.

***

4. Carol Bennett, Consumers Health Forum of Australia

Is this recommendation worth pursuing? Yes, although it is obviously a goal or stretch target rather than something that can be quickly or easily achieved.

What are some of the issues that will need to be addressed? For common measures of efficacy, there will need to be common measures of patient outcomes which will need to include the experience of care – i.e. the degree to which health consumers felt the treatment matched their health needs rather than the degree to which the service provided matched some rigid standard of procedure.

What impact might it have if it was implemented? If health consumers were properly informed about likely outcomes from the full range of health interventions available, it would allow consumers to have greater control and ownership of their own health and well being. Obviously this would lead to a much more healthy community. At present, whichever procedural specialist you see, whether they be a surgeon or a gym instructor, they will be bias towards the efficacy of the services they provide.

Do you think that it has any chance of being implemented? What might be some of the barriers? This has very little chance of being implemented in the short to medium term primarily because existing health providers generally like to measure their performance against the efficacy of their agreed procedures rather than comparing real health outcomes for consumers. We need to make health outcomes for consumers the focus of evaluation, not the procedures that are currently used. A good model in the general practice setting is the Collaboratives program which focusses on health outcomes.

Are you aware of any other countries that are already doing this? Increasingly countries like the UK are looking to health consumer outcomes as the primary reference point for efficacy of any procedure or health intervention, but it still has a long way to go before it becomes a realised ambition as outlined in the recommendation of the NHHRC.

Any other general issues that are worth raising? While the goal may be a long way away, any step to provide better information to health consumers about the outcome of a range of possible interventions is to be encouraged and supported.

***

5. Public health physician George Rubin

What are some of the issues that will need to be addressed? National mechanism/s for conducting the reviews – a network of organisations under the auspices of NHMRC; methods agreed and developed …perhaps along the line of the evolution of systematic reviews

What impact might it have if it was implemented? Gradual shift of practice towards interventions of demonstrated effectiveness; hopefully a mechanism for ongoing assessment of interventions for which there is little or no evidence; reduction of interventions proven ineffective

Do you think that it has any chance of being implemented? What might be some of the barriers? Little chance. It will take a major organisational effort, will need a substantial budget (which could be saved by a successful program) and will involve substantial politics around what potentially gets dropped. More realistic to develop a program of comparative effectiveness measurement. Are you aware of any other countries that are already doing this? Health technology assessment organisations in NZ, Canada, US etc but unaware of comparative assessment programs

***

6. Michael Moore, Public Health Association

I think that there is some merit in pursuing the recommendation. However, I do have some reservations about how the comparative research might be conducted and the prism through which such research might be constructed. Over the last decades preventive and public health has been the poor cousin in research because it is not simply about a gold standard double blind study with all confounding factors eliminated.

The medical and the pharmaceutical research methodology is likely to be more easily understood and therefore carry a favourable bias. I am not sure how these concerns might be met. A sensible study that wrestled and dealt with those issues has the potential to provide some serious insights into the most effective methods of dealing with obesity providing opportunity for governments to determine the most effective allocation of resources.

Implementation will be difficult as I suspect the funding of broad ranging research across different disciplines as this will demand is likely to be very expensive. However, it is possible and could be achieved by letting a tender to a consortium capable of crossing the barriers.

The complexity of obesity, the structural issues that drive it and the role of junk foods is probably a higher priority for research funds.

***

7. Ben Harris-Roxas, Research Fellow, Healthy Public Policy Program, University of NSW

At time when we face increasingly complex health issues that are caused by multiple factors such as the way we live, work and take care of ourselves this may lead us further down the path to simple answers.

Also it’s unclear what methods might actually be used to compare interventions, e.g. cost-effectiveness studies, health technology assessment, etc. It’s not like issues of effectiveness will be examined independent of cost, so we should really be calling it what it is – a discussion about which intervention(s) should be funded based on their comparative cost effectiveness.

What impact might it have if it was implemented? I think it would tend to concentrate preventive activities even further on simple, well tested interventions that are closely tied to health outcomes, i.e. not complicated by other factors. This is not a bad thing in of itself, but it could stifle innovation and may only address the underlying issues at the margins.

Do you think that it has any chance of being implemented? What might be some of the barriers? It depends what the purpose of the “national approach” is. Will it be to ensure that only effective interventions get used or to decide that only a limited number of the most cost-effective interventions will be funded? Getting the states and the Commonwealth to agree on a common approach to this will be a minor miracle. The other issue is that the capacity to do health economic analysis is exceedingly weak at the state level and quite patchy at the Commonwealth level. The ability of drug manufacturers to demonstrate their products’ cost effectiveness is beter developed than, say, people developing population-based interventions, partly due to the nature of the interventions and outcomes but also because they are already doing cost-effectiveness studies for the PBAC/MSAC. The other problem is that it will favour one or two interventions as being the most cost-effective, when much of the emphasis in population health research is shifting to using complex interventions for complex problems.

Are you aware of any other countries that are already doing this? The UK’s National Institute for Health and Clinical Excellence (NICE) do this to a certain extent and the conventional wisdom is that they will only recommend that a drug or procedure gets funded if it costs less than £30,000/QALY.

If the “national approach” is only to set a minimum benchmark for cost effectiveness of interventions we may encounter a situation where

• costs grow rapidly (as currently occurs once drugs are apporved by PBAC or procedures by MSAC),

• there are increased inequalities in the health outcomes, and

• there will be concern about funding more and more interventions, suggesting that the benchmark threshold will have to be revised regularly.

A broader discussion is required about how much we are willing to pay as a nation and society for our health and how much we’re willing to invest in an average individuals’ health, but that’s too politically sensitive to contemplate in the forseeable future. If the purpose of the “national approach” is to ration services, and it would have to be at some level, this debate will have to occur.

Any other general issues that are worth raising? Transparency of the process will be important. Also, how do we circumscribe our consideration of effective interventions for health. For example, a recent meta-analysis of the lifetime effects of education on quality of life made a conservative cost estimate of between €98,000 and €168,000 for every QALY gained [Furnee CA, Groot W, van den Brink HM. The Health Effects of Education: A meta-analysis. European Journal of Public Health 2008;18(4):417-21.], and this didn’t quantify the effects such as the impact of education on mortality.

Education has a number of other positive impacts beyond direct health gains – should we be funding education as a cost effective health intervention?

***

8. Wayne Hall, School of Population Health, University of Queensland

What are some of the issues that will need to be addressed if this is to be implemented? Something along the lines of the Pharmaceutical Benefits Advisory Council would need to be set up to evaluate major interventions in fields of high public health priority. Given the demands on expertise and time to do these analyses such an approach would probably have to be phased in.

What impact might it have if it was implemented? It would put the onus of proof on advocates of new approaches to provide evidence not just of their safety and efficacy but their cost-effectiveness compared to other similar interventions directed at the same risk factor or disease. It would make government think more strategically about funding for health care interventions rather than make piecemeal decisions about things one at a time (as we do with drugs with PBAC with limited capacity to revisit past decisions in the light of new interventions)

Do you think that it has any chance of being implemented? What might be some of the barriers? Barriers will be many: special interest groups (e.g. food industry, diet industry, pharmaceutical industry, health professionals with an investment in particular approaches); the economic costs to govt of implementing and scaling up such a system of evaluation; lack of data for economic evaluations etc etc

Are you aware of any other countries that are already doing this? NICE in the UK attempts to do something along these lines in so far as data permit for major areas of public health concern. Rob Carter from Deakin and Theo Vos at UQ are undertaking this sort of project at present for an NHMRC funded grant. Rob has done something along the lines suggested on obesity interventions and Theo something similar on alcohol.

Any other general issues that are worth raising? It’s an idea that needs to be seriously discussed and trialed in a couple of key areas of current public health concern, e.g. obesity

***

9. Glenn Salkeld, School of Public Health, University of Sydney

What are some of the issues that will need to be addressed? Common issues – is there a common metric of health outcome that captures what matters? (ie the stated objectives of government health expenditure) Where does the information for the evaluation come from and is it valid and reliable? Who (an independent body or not) and what governs the assessment of the evaluation (is it regulation, legislation?) How does the process manage competing interests (of both buyers and sellers of health interventions/products)? What impact might it have if it was implemented? It would slow things down and allow time for proper debate on the best use of scarce resources. Depending on the responses to questions 1 & 2, it has the potential to shift resource allocation to a more transparent process (and hopefully move resource allocation to a more considered and defensible basis)

Do you think that it has any chance of being implemented? What might be some of the barriers? It will require a good deal of courage. It has worked in the pharmaceutical area because the only way to sustain large public expenditure that benefits the population and the sellers of medicines is to have an evidence-based approach to the selection and reimbursement of drugs. Without the public subsidy both sides lose. With a credible way to allocate money for medicines both sides gain. Are you aware of any other countries that are already doing this? The UK has the National Institute for Clinical Effectiveness (NICE) but that functions in the context of a more planned health service.

Any other general issues that are worth raising? Without a national approach to better resource allocation in health we will struggle to exert any control over who gets what health resources and how much. Doing nothing will only increase health inequalities.

***

10. Les Irwig, School of Public Health, University of Sydney

My quick reaction is:

• Great idea!

• will need massive Govt funding to avoid the problem of RCTs being more likely for new pharmaceuticals.

• non-drug interventions used in the trials will need good descriptions – see Paul Glasziou’s recent paper in the BMJ on how poorly they are described currently in the lit

• need better consumer/patient involvement to define what endpoints are meaningful to patients and therefore should be measured in the trials

• pity they didn’t include diagnostic technology, for which far more trials should be done

**

11. Lloyd Sansom, Chair, Pharmaceutical Benefits Advisory Committee

The Government is currently undertaking a Health Technology Assessment and one of the issues they are examining is the relationship between the various agencies particularly in regard to hybrid technologies and timeliness . With increasing applications of molecular targeted drugs, drug/device combinations it is important that we examine the situation to improve the efficiency of the process.

The PBAC submission to the review is here.  In view of the current review it would be inappropriate for me to make any other comment other than the submission

***

12. Jon Jureidini, Adelaide psychiatrist and member, Healthy Skepticism

It could have a dramatic impact in some areas, but would require significant and often unpopular disinvestment. There would be some practical barriers, but the political ones will be stronger.

***

13. Libby Roughead, School of Pharmacy and Medical Sciences, University of SA

Very often in health care we need implementation of a mix of strategies, not just one, so there needs to be a context in which this recommendation is considered. That being said if we only evaluate pharmaceuticals against pharmaceuticals, then we might not understand how that compares with other interventions which may be less or more effective – which I suspect is the issue trying to be raised.

If you look at the US Institute of Medicine’s top 100 priorities for comparative effectiveness, you will see that many of those are about gathering evidence for the mix of health care interventions – although I gather the top 100 priorities were opinion-based supported by a nominal group process rather than based on other data.

It is certainly a good idea to think about how public health dollars and practice and primary health dollars and care may be better integrated and how the evidence may integrate – we will always need both strategies (not just one or the other).

The challenge is creating the incentive for developing the evidence – it is work rarely done and we already have a challenge of evidence just within areas of health care. I suspect the starting point is to create the dialogue about what this means – as Croakey is doing.

The new entries are Professor Simon Stewart, Head, Preventive Cardiology at the Baker IDI Heart and Diabetes Institute, and his colleague, Dr Melinda Carrington, General Manager of the Baker’s Disease Management and Preventative Programs.

They appeared in an advertorial promoting cholesterol treatment sponsored by Astra Zeneca, and published this month in Medical Observer magazine. They were quoted discussing the findings of a study of patients taking cholesterol medication that was funded by Astra Zeneca, and designed and conducted by the Baker.

The advertorial is particularly noteworthy for a few reasons:

• The close links between the Baker and pharmaceutical industry marketing are already the subject of considerable controversy, with the Medicines Australia code of conduct committee recently upholding a complaint over another campaign featuring the Baker.

• Last year in this Crikey story, the head of the NHMRC, Professor Warwick Anderson called for an end to doctors and other health professionals participating in such advertorials. Anderson was, in a former life, Deputy Director of the Baker Medical Research Institute. It may simply be a coincidence, but there do seem to be far fewer experts popping up in pharma advertising in Australian Doctor and Medical Observer since Anderson’s statement.  So the Astra Zeneca one really does stand out and is likely to be attracting quite a bit of comment in quarters concerned about conflicts of interest arising from close relationships between individuals, institutions and industry.

Meanwhile, on related topics, a campaigning US Senator is leading a charge for medical schools in the US to disclose their  policies on conflicts of interest and requirements for disclosure of financial ties between staff members and drug firms.

The British Medical Journal recently reported that Senator Chuck Grassley, an Iowa Republican who is the leading minority member on the Senate Committee on Finance, wrote to 23 medical schools that had not completed a survey by the American Medical Student Association.

The student association surveyed all 146 medical schools, of which 126 provided information about their policies. The association posted the results on its PharmFree Scorecard website and graded the schools’ policies from A to F (failing).

Senator Grassley asked the 23 schools to provide a copy of their conflict of interest policy, their communications with the NIH about conflicts of interest and research by their professors, the amount of grant funds from the NIH and other federal grants received by the institution from 2004 through 2008, and for the names of the principal investigators for each grant.

Senator Grassley’s letter, a press release, and a list of the 23 schools are here.

You have to pay for full access to the BMJ article but the abstract is freely available here.

Croakey welcomes feedback from those named on the Register, and will gladly publish their responses.

:

“…under the requirements of the Therapeutic Goods Act (1989), the Therapeutic Goods Advertising Code (2007) and as stipulated in the Therapeutic Good Administration’s letter of marketing approval, Sponsor promotionof all prescription products (whether member or non-member) is required to comply with the requirements of the Medicines Australia code of conduct.  Members of the Generic Medicines Industry Association are required to comply with the Medicines Australia code of conduct.”

More info here also.

Harvey adds:  “What is interesting is that Sigma is a GMiA member. Given the above, I don’t see how Sigma can wiggle out of this one!”

Meanwhile, Medicines Australia has advised Harvey that it expects Sigma will decline to appear before its code of conduct committee…

Just for the record, Sigma has told the pharma industry news service, Pharma in Focus, that the cruise has nothing to do with promoting medicines and that suggestions to the contrary are “completely false”.

Sigma CEO Elmo de Alwis told the publication that the trip was  a networking and educational opportunity for doctors, many of whom had attended previous cruises put together by the company – although he did acknowledge that the event gave company reps better access to GPs…

Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, is reliably quick off the mark on these matters.  He’s already submitted a complaint to the Medicines Australia Code of Conduct Committee and has also sent the letter below to Mark Butler, the Parliamentary Secretary for Health. The letter is reproduced with Harvey’s permission.

Dear Mr Butler,

Re: Sigma Mediterranean Conference for GPs and Pharmacists; TGA and Ethical Codes of Conduct

I have attached advertisements and appended media coverage about this event which appears to breach Section 6.2 (hospitality), 6.4 (sponsorship) and 6.6 (venue) of Medicines Australia Code of Conduct.

However, Sigma, not being a member of Medicines Australia, has argued in the past that they are not subject to the provisions of Medicines Australia Code regarding such matters. I have also been told that the Therapeutic Goods Administration (TGA) supports Sigma’s view.

TGA’s letter of marketing approval requires the promotion of all prescription products (whether member or non-member) to comply with the requirements of the Medicines Australia Code of Conduct. In addition, the Therapeutic Goods Act 1989 notes that advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Clearly, the purpose of Sigma organising and promoting a 10-day Mediterranean cruise for doctors and pharmacists (with only one and a half days educational content) is to promote the use and supply of their products.

It seems self-evident that Medicines Australia Code should apply to this event and I cannot understand why the TGA has adopted a contrary view.

I should be grateful if, on my behalf, you could ask the TGA for an explanation of their ruling.

This Sigma event is yet another example of inconsistencies and double standards of Australian co- regulatory systems aimed at controlling unethical promotional practices.

Currently, Australia has a variety of complex and convoluted co-regulatory systems to control unethical therapeutic claims and promotional practices depending upon the type of product (innovator and generic prescription, over-the-counter and complementary medicines, therapeutic devices, food and cosmetics) and the media in which claims are made.

There are different standards and gross inconsistencies between various Codes of Conduct, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness (see also: Harvey K. A review of proposals to reform the regulation of complementary medicines. Aust Health Rev 2009: 33(2); 279-285. )

In addition, the different jurisdictions involved in therapeutic claims made for “nutraceuticals” (functional foods) and “cosmaceuticals” (cosmetics) create additional problems.

It is time that this mess was simplified and unified by creating one Code applicable to all therapeutic claims and promotional practice; one complaint (and appeal) process, one monitoring process and one set of effective sanctions, including corrective advertising orders and fines related
to the sales income of the product and company involved. The process should be overseen by government, funded by industry (using a moiety of product registration fees), and administered by an independent committee representative of all stakeholders. The system should have a legislative base in the Therapeutic Goods Act &/or regulations and be capable of being enforced. South African legislation provides a model of such a broader system (involving all types of medicines).

In May 2007, Australia (and other member states) adopted World Health Assembly Resolution WHA 60.16.5 on Rational Use of Medicines. This urged member states to, “Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, non-promotional information about medicines”.

I have proposed (to the recent National Medicines Policy Forum) that the National Medicines Policy Committee set up a working party to consolidate the multiple existing Codes into a single Code and draft suitable enabling legislation.

I should be grateful for your response to this proposal which, I believe, would be a practical demonstration of Australian commitment to WHA Resolution 60.16.5.

Yours sincerely,
Dr Ken Harvey

• Croakey will keep you posted on any responses to Ken Harvey’s letters